Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-24 @ 2:55 PM
NCT ID:
NCT00629759
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years
* Patients with hepatic carcinoma (primary or metastatic) clinically or histologically confirmed to have tumors (≤10cm maximum diameter) that are progressing (refractory to standard treatment) despite regular treatment and that can be transdermally accessed by an injection needle in an imaging-guided procedure
* Tumor progression despite undergoing regular treatment such as surgery, transarterial chemoembolization, chemotherapy, and radiotherapy
* Performance score: Karnofsky Performance Score (KPS) ≥70
* Expected survival of at least 16 weeks
* For patients who are sexually active, able and willing to use contraceptives for a three month period during and after taking JX-594
* WBC \> 3,500 cells/mm3
* ANC \> 1,500 cells/mm3
* Hemoglobin \> 10g/dL
* Platelet count \> 75,000 plts/mm3
* Serum creatinine \< 1.5 mg/dL
* AST, ALT \< 2.5 x ULN
* Total bilirubin ≤ 2.0 mg/dL
* In patients with primary HCC, Child Pugh A or B
* Able/willing to sign an IRB/IEC/REB-approved written consent form
* Able and willing to comply with study procedures and follow-up examinations
Exclusion Criteria:
* Pregnant or nursing an infant
* Known infection with HIV
* Clinically significant active infection or uncontrolled medical condition considered high risk for investigational new drug treatment
* Significant immunodeficiency due to underlying illness (e.g. hematological malignancies, congenital immunodeficiencies and/or HIV infection/AIDS) and/or medication (e.g. high-dose systemic corticosteroids)
* Patients with household contacts with significant immunodeficiency
* History of exfoliative skin condition (e.g. severe eczema, ectopic dermatitis, or similar skin disorder) that at some stage has required systemic therapy
* Severe or unstable cardiac disease
* Use of adrenal cortical hormone drug or immunosuppressant within four weeks of study enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00629759
Study Brief:
Protocol Section:
NCT00629759